AVOBENZONE, HOMOSALATE, OCTISALATE- avobenzone, homosalate, octisalate lotion 
Old East Main CO.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen Lotion for Babies SPF 50
D47AA/D47.001

Active ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away.

Directions

Other information

inactive ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol

Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Lotion Water Babies Broad Spectrum SPF 50.

May stain or damage some fabrics or surfaces

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888)309-9030

Principal Panel Display

STUDIO SELECTION SUN

SUNSCREEN LOTION FOR 

babies

BROAD SPECTRUM SPF 50

Compare to Coppertone® Water Babies Broad Spectrum SPF 50

SPF 50
Pediatrician-Tested

Hypoallergenic

8 FL OZ (236 mL)

image description

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-947
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate120 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYESTER-7 (UNII: 0841698D2F)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DOCOSANOL (UNII: 9G1OE216XY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
GERANIOL (UNII: L837108USY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-947-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/31/2023
Labeler - Old East Main CO. (006946172)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon. LLC790752542manufacture(75712-947)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(75712-947)

Revised: 8/2023
Document Id: 130f99c0-dc21-4b23-a77e-52ae0bc82d33
Set id: ce9a2139-c5c2-43e2-bd51-1f14ace594d9
Version: 1
Effective Time: 20230831
 
Old East Main CO.